"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

In this paper the need for valid evidence of the cost-effectiveness of treatments that have not been properly evaluated, yet are already available, albeit in short supply, are examined. Such treatments cannot be withdrawn, pending proper evaluation, nor can they be made more widely available until they have been shown to be cost-effective. As a solution to this impasse the argument put forward recently by Toroyan et al is discussed. They say that randomised controlled trials of such resources could be (...) done but only if resources are randomly allocated independently of a research context. Relevant outcome data could then be collected for research, given this opportunity. We agree. We disagree with Toroyan et al on a number of points. First, they claim that no ethical issue relating to equipoise arises. We disagree and this disagreement depends on our showing that equipoise should be maintained in a relationship that they do not consider. Secondly, they say that consent to data collection is always needed. Again we disagree. Thirdly, they claim that the previous two issues are the only possible ethical issues that could arise. We argue, instead, that there is a further conflict of interests that has ethical import. (shrink)

During a pandemic, where there is widespread human infection, various and varying measures are taken that are targeted at public health objectives. During the early stages of a pandemic, these objectives may focus on containing the disease and minimizing its spread, but they may switch to mitigation as the emergent infectious disease takes hold in a population. There has been considerable debate and elucidation of the ethical principles and framework for the various responses including the need to fast track research (...) and vaccine development. However, the measures imposed during a pandemic would have unintended and untoward effect on ongoing clinical research. For example, precautionary measures, such as social distancing, may hamper ongoing clinical research, because recruitment and participation of patients and healthy volunteers is a potential source of virus spread. In this paper, we argue that a framework is needed to ensure the continuity of such research. Such a framework that considers the pertinent issues would need the ‘buy in’ of the key stakeholders (policy makers, funding agencies, institutional authorities, researchers and subjects) to ensure that the issues that are ethically relevant to pandemic planning would not be neglected or overlooked. (shrink)

Most academic papers on ethics in pandemics concentrate on the duties of healthcare professionals. This paper will consider non-professional healthcare workers: do they have a moral obligation to work during an influenza pandemic? If so, is this an obligation that outweighs others they might have, e.g., as parents, and should such an obligation be backed up by the coercive power of law? This paper considers whether non-professional healthcare workers—porters, domestic service workers, catering staff, clerks, IT support workers, etc.—have an obligation (...) to work during an influenza pandemic. It uses data collected as part of a study looking at the attitudes of healthcare workers to working during a pandemic to suggest the philosophical arguments explored. These include: being in a position to do good, the ethics of work, competing obligations to family members and in particular to children and the obligations of citizens in a state of national emergency. We also look at whether compulsory measures are justified to support a national health service during a health emergency. We conclude that even if they are, compulsion should not be restricted to non-professionals who happen to be working in the health service at the time. Rather, compulsion involving a larger pool of people with the relevant skills and abilities is more equitable. (shrink)

Institute for Biomedical Ethics, Geneva University Medical School * Corresponding author: Médecins Sans Frontières (OCG), rue de Lausanne 78, CH-1211 Geneva 21, Switzerland. Tel.: +41 (0)22 849 89 29; Fax: +41 (0)22 849 84 88; Email: philippe_calain{at}hotmail.com ' + u + '@' + d + ' '//--> Abstract Outbreaks of filovirus (Ebola and Marburg) hemorrhagic fevers in Africa are typically the theater of rescue activities involving international experts and agencies tasked with reinforcing national authorities in clinical management, biological diagnosis, sanitation, (...) public health surveillance and coordination. These outbreaks can be seen as a paradigm for ethical issues posed by epidemic emergencies, through the convergence of such themes as: isolation and quarantine, privacy and confidentiality and the interpretation of ethical norms across different ethnocultural settings. With an emphasis on the boundaries between public health investigations and research, this article reviews specific challenges, past practices and current normative documents relevant to the application of ethical standards in the course of outbreaks of filovirus hemorrhagic fevers. Aside from commonly identified issues of informed consent and institutional review processes, we argue for more clarity over the specification of which communities are expected to share benefits, and we advocate for the use of collective definitions of duty to care and standard of care. We propose new elaborations around existing normative instruments, and we suggest some pathways toward more comprehensive approaches to the ethics of research in outbreak situations. CiteULike Connotea Del.icio.us What's this? (shrink)

In this book, he applies economic theory to four areas of interest to students of social and legal institutions: the theory of justice, primitive and ancient ...

Agents sometimes feel free to resort to underhand or brutal measures in coping with an emergency. Because emergencies seem to relax moral inhibitions as well as carrying the risk of great loss of life or injury, it may seem morally urgent to prevent them or curtail them as far as possible. I discuss some cases of private emergency that go against this suggestion. Prevention seems morally urgent primarily in the case of public emergencies. But these are the responsibility of defensibly (...) partisan agents, and call for the exercise of powers that are legitimately hard to control. Philosophical standards for dealing with public emergency often ignore these facts, and are unduly moralistic as a result. (shrink)

The central issue that I consider in this paper is the use of the so‐called ‘Rule of Rescue’ in the context of resource allocation. This ‘Rule’ has played an important role in resource allocation decisions in various parts of the world. It was invoked in Ontario to overturn a decision not to fund treatment for Gaucher's Disease and it has also been used to justify resource decisions in Israel concerning the same condition. -/- In the paper I consider the nature (...) of the Rule of Rescue and its moral justification. The latter involves consideration of the distinction between agent‐relative and agent‐neutral obligations. If the Rule of Rescue is to be justified, it is plausible to think that it will be in the context of agent‐relative obligations. Two problems with this suggestion are considered: the role of identifiability in the Rule of Rescue and the extent to which policy makers in a health care system can be taken to have such obligations. It is argued that in both cases these problems can be overcome and hence that there is a prima facie obligation to follow the Rule of Rescue. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)

Making research data readily accessible during a public health emergency can have profound effects on our response capabilities. The moral milieu of this data sharing has not yet been adequately explored. This article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies. There are three notable reasons that stand in opposition to a duty to share one’s data, relating to: (i) data property and ownership, (ii) (...) just distribution of benefits and burdens and (iii) the contemporary ethos of science. We argue each reason can be successfully met with corresponding rationale in favour of data sharing. Further support for data sharing has been echoed in policies of health agencies, funding bodies and academic institutions; in documents on the ethical conduct of biomedical research; and in discussions on the nature of public health. From this, we ascertain that sharing data is the morally sound default position. This article then highlights the key roles reciprocity and solidarity play in supporting the practice of data sharing. We conclude with recommendations to regard public health research data as a common-pool resource in order to build a framework for stable data sharing management. (shrink)